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On the estimation of total variability in assay validation.

Publication ,  Journal Article
Chow, SC; Tse, SK
Published in: Stat Med
October 1991

In the pharmaceutical industry, an assay method is considered validated if the accuracy and precision for an assay meet some acceptable limits. This paper discusses the assessment of assay precision in terms of the estimation of total variability of an assay from a one-way random effects model which is often considered in assay validation. We propose a general class of estimators that includes the analysis of variance estimator and the maximum likelihood estimator. We derive the optimal estimator, in terms of smallest mean squared error, within this class and consider an approximate version of this optimal estimator. We report on a Monte Carlo simulation to study its finite sample performance. We also present two examples to illustrate the use of the proposed methodology.

Duke Scholars

Published In

Stat Med

DOI

ISSN

0277-6715

Publication Date

October 1991

Volume

10

Issue

10

Start / End Page

1543 / 1553

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Monte Carlo Method
  • Models, Statistical
  • Drug Evaluation, Preclinical
  • Clinical Trials as Topic
  • Biopharmaceutics
  • Analysis of Variance
  • 4905 Statistics
 

Citation

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Chow, S. C., & Tse, S. K. (1991). On the estimation of total variability in assay validation. Stat Med, 10(10), 1543–1553. https://doi.org/10.1002/sim.4780101006
Chow, S. C., and S. K. Tse. “On the estimation of total variability in assay validation.Stat Med 10, no. 10 (October 1991): 1543–53. https://doi.org/10.1002/sim.4780101006.
Chow SC, Tse SK. On the estimation of total variability in assay validation. Stat Med. 1991 Oct;10(10):1543–53.
Chow, S. C., and S. K. Tse. “On the estimation of total variability in assay validation.Stat Med, vol. 10, no. 10, Oct. 1991, pp. 1543–53. Pubmed, doi:10.1002/sim.4780101006.
Chow SC, Tse SK. On the estimation of total variability in assay validation. Stat Med. 1991 Oct;10(10):1543–1553.
Journal cover image

Published In

Stat Med

DOI

ISSN

0277-6715

Publication Date

October 1991

Volume

10

Issue

10

Start / End Page

1543 / 1553

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Statistics & Probability
  • Monte Carlo Method
  • Models, Statistical
  • Drug Evaluation, Preclinical
  • Clinical Trials as Topic
  • Biopharmaceutics
  • Analysis of Variance
  • 4905 Statistics